4th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 22-25 September 2002, San Diego, CA, USA

GLUCOSE METABOLISM ABNORMALITIES ASSOCIATED WITH HIGHLY ACTIVE ANTIRETROVIRAL THERAPY: A COHORT STUDY

Antiviral Therapy 2002; 7:L25 (abstract 35)

T Quirino, P Bonfanti, I Faggion, E Ricci, C Martinelli, L Valsecchi, S Carradori, L Pusterla, P Fortuna, L Timillero, S Miccolis, C Magnani, S Landonio, A Gabbuti and GM Vigevani
CISAI Group, Mario Negri Institute for Pharmacological Research, Milan, Italy

OBJECTIVE: To assess the incidence of hyperglycaemia in HIV-positive patients receiving antiretroviral therapy including at least one protease inhibitor (PI).

METHODS: In order to establish the incidence of adverse events (AE) during treatment with a PI, we designed a multicentre, prospective, cohort study in patients starting therapy with a highly active antiretroviral therapy (HAART) regimen including a PI. The study started in September 1997 and involved ten infectious diseases departments in northern Italian hospitals belonging to the CISAI group. As of September 2000, 1481 patients had been enrolled, and the present analysis refers to their follow-up for the next 12 months. All had blood chemistry tests at least every 2 months. We rated the severity of AE using the ACTH adverse experience grading scale.

RESULTS: The 1481 patients’ mean age was 37.1 years (SD ±8.1); 1066 (72.2%) were men. The mean followup was 22.2 months (range 0-37). Mean CD4 lymphocyte count at enrolment was 265 cells/mm³ (SD ±201). Abnormalities of the glucose metabolism were detected in 32 patients (2%); eight had blood glucose raised to grade 3 or 4. All had to suspend therapy. The incidence of blood glucose abnormalities per 100 person-years of treatment was 1.92 (95% confidence interval [CI] 1.70-2.14) for ritonavir/saquinavir, 1.36 (95% CI 1.30-1.42) for indinavir, 0.96 (95% CI 0.87-1.06) for nelfinavir, 0.70 (95% CI 0.63-0.76) for saquinavir and 0.66 (95% CI 0.57-0.75) for ritonavir. Hyperglycaemia appeared during the first year of treatment in 17 cases (53.1%), in the second year in 12 (37.5%) and after 24 months in 3 (9.4%).

CONCLUSION: The frequency of hyperglycaemia in this cohort is similar to that reported by others. This AE may appear late – after the first year of therapy in 46.9% of patients – and often obliges them to stop treatment. It is therefore mandatory to keep a close watch for these alterations, particularly in patients with risk factors such as a family history of related dysfunctions, or blood lipid disorders.

This study was supported by an ISS grant from the Italian Ministry of Health, Rome, Italy

Presenting author: T Quirino

2002-09-22
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